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FDA 510(k) Applications Submitted by BECKMAN COULTER IRELAND INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K142346
08/22/2014
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
Beckman Coulter Ireland Inc.
K182651
09/24/2018
HbA1c Advanced
Beckman Coulter Ireland Inc.
K161297
05/09/2016
Beta-2-Microglobulin
Beckman Coulter Ireland Inc.
K161508
06/01/2016
Ceruloplasmin
BECKMAN COULTER IRELAND INC.
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